我国药品质量监督抽验情况分析及建议

Analysis and Suggestions for Supervision and Sampling Test of Drug Quality in China

目的:为完善我国药品监督抽验管理,提高我国药品监督抽验水平提供参考。方法:基于对我国现行药品抽验管理相关规定的了解,通过对国家食品药品监督管理总局(CFDA)2011-2014年公布的药品质量公告中相关数据进行统计分析,采用逻辑推理的方法对目前我国药品监督抽验存在的问题进行探讨。结果与结论:目前,我国药品监督抽验存在过于偏重国家基本药物、资源浪费、监管力量相对不足、检验技术未能有效发挥技术支撑作用等问题。建议通过合理制订抽验计划、改善抽验模式以及使用新兴药品监管技术,缓解目前我国药品监管中存在的问题。

Objective To provide suggestions for improving the management and level of supervision andsampling test of drugs in China. Methods： The relevant data of published drug quality announcement by CFDAfrom 2011 to 2014 were statistically analyzed based on the understanding of relevant provisions of managementof current sampling test of drugs in China. Current problems of supervision and sampling test of drugs in Chinawere discussed by using the method of logical reasoning. Results and Conclusion： The current problems ofsupervision and sampling test of drugs in China exist in the following aspects： overemphasis on national essentialdrugs, serious waste of resources, relative lack of supervision, and insufficient fulfillment of role of technicalsupport of testing technologies. It was suggested that the problems in the current supervision of drugs in Chinashould be alleviated by making a reasonable sampling test plan, improving the sampling test mode and utilizingthe new regulatory technologies of drugs.